In order to bring products to the market, it is mandatory for medical device manufacturers to have a Quality Management System (QMS) in place. We can assist you to achieve this end with the following services:
- Establishment and implementation of Quality Management Systems (QMS).
- Preparation for certification of Quality Management Systems (QMS) according to FDA QSR, EU Directives (AIMD, MDD, and IVD) and Regulations (MDR and IVDR), EN/ISO13485 and MDSAP,
- Liaison with Certification Bodies.
- Pre-certification audits prior to FDA audits, Notified Body Audits or other bodies.
- Periodic compliance First and Second party Audits including Mock Audits.
- Maintenance of Quality Management Systems (QMS) and acting as your Quality Assurance Manager.